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DRUG:

Trodelvy (sacituzumab govitecan-hziy)

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Other names: RS7-SN38, hMN14-SN38, TROP-2-SN-38, hRS7-SN38 antibody drug conjugate, hRS7-SN 38, anti-TROP-2-SN-38 conjugate, IMMU-132, IMMU132, IMMU 132, anti-TROP-2-SN-38, hRS7-CL2-SN-38, IMMU0132, GS-0132
Company:
Gilead
Drug class:
Topoisomerase I inhibitor, TROP-2-targeted antibody-drug conjugate
Related drugs:
20h
New P1/2 trial
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HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • UGT1A1 (UDP glucuronosyltransferase family 1 member A1)
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Trodelvy (sacituzumab govitecan-hziy) • Neupogen (filgrastim)
22h
New P2 trial • Platinum sensitive
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BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency)
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BRCA2 mutation • BRCA1 mutation • HRD
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Avastin (bevacizumab) • carboplatin • gemcitabine • pegylated liposomal doxorubicin • Trodelvy (sacituzumab govitecan-hziy) • Aybintio (bevacizumab biosimilar) • Vegzelma (bevacizumab-adcd) • Avzivi (bevacizumab-tnjn) • Myocet (non-pegylated liposomal doxorubicin) • Duomeisu (pegylated liposomal doxorubicin)
1d
Cost-Effectiveness Analysis of Sacituzumab Govitecan Versus Chemotherapy for the Treatment of Metastatic Triple-Negative Breast Cancer With Different Trophoblast Cell-Surface Antigen 2 Expression Levels in Chinese Mainland. (PubMed, Value Health Reg Issues)
In conclusion, although SG is clinically effective for mTNBC, its high cost makes it economically unfeasible in mainland China. A substantial price reduction is essential for it to become a viable option, enabling more patients to benefit from its therapeutic potential.
Journal • HEOR • Cost-effectiveness
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TACSTD2 (Tumor Associated Calcium Signal Transducer 2)
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Trodelvy (sacituzumab govitecan-hziy)
1d
Effectiveness, safety, and biomarker analysis of sacituzumab govitecan in Chinese metastatic breast cancer: a multicenter real-world study. (PubMed, Ther Adv Med Oncol)
In conclusion, SG showed similar effectiveness with ASCENT and TROPiCS-02 study in heavily pretreated Chinese MBC patients. Given the compromised effectiveness in patients with prior PD-1/PD-L1 inhibitors or PIK3CA mutation, future investigations are warranted to explore SG-based combination regimens or novel therapeutic strategies in the above population.
Journal • Real-world evidence • PD(L)-1 Biomarker • IO biomarker
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HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
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HR positive • HER-2 negative • PIK3CA mutation
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Trodelvy (sacituzumab govitecan-hziy)
2d
Sacituzumab Govitecan in Recurrent Glioblastoma (clinicaltrials.gov)
P2, N=32, Recruiting, The University of Texas Health Science Center at San Antonio | Trial completion date: Aug 2026 --> Feb 2028 | Trial primary completion date: Feb 2026 --> Feb 2027
Trial completion date • Trial primary completion date
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MGMT (6-O-methylguanine-DNA methyltransferase) • TACSTD2 (Tumor Associated Calcium Signal Transducer 2)
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IDH wild-type
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Trodelvy (sacituzumab govitecan-hziy)
5d
SURE-01: Sacituzumab Govitecan, Preceding Radical Cystectomy, in Treating Patients With Muscle-invasive Bladder Cancer (clinicaltrials.gov)
P2, N=44, Completed, IRCCS San Raffaele | Trial completion date: Jun 2025 --> Sep 2025 | Trial primary completion date: Jun 2025 --> Sep 2025 | Recruiting --> Completed
Trial completion • Trial completion date • Trial primary completion date
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cisplatin • irinotecan • Trodelvy (sacituzumab govitecan-hziy)
6d
Sacituzumab govitecan in Japanese participants with HR+/HER2- metastatic breast cancer: primary results from the phase II ASCENT-J02 study. (PubMed, Jpn J Clin Oncol)
Although the primary endpoint (ORR by IRC) was not met (P > .025), overall efficacy results were generally similar to TROPiCS-02, supporting access to SG in Japanese patients with HR+/HER2- mBC. Safety was consistent with the known and manageable SG safety profile.
P2 data • Journal
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HER-2 (Human epidermal growth factor receptor 2)
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HR positive • HER-2 negative • EGFR positive
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Trodelvy (sacituzumab govitecan-hziy)
8d
New P2 trial • IO biomarker
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Trodelvy (sacituzumab govitecan-hziy) • Cotelet (tagitanlimab)
9d
A Phase I/II Study of Sacituzumab Govitecan Plus Berzosertib in Small Cell Lung Cancer, Extra-Pulmonary Small Cell Neuroendocrine Cancer and Homologous Recombination-Deficient Cancers Resistant to PARP Inhibitors (clinicaltrials.gov)
P1/2, N=120, Recruiting, National Cancer Institute (NCI) | Trial completion date: Mar 2027 --> Mar 2029 | Trial primary completion date: Mar 2026 --> Mar 2028
Trial completion date • Trial primary completion date
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BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency) • CDK12 (Cyclin dependent kinase 12) • BRCA (Breast cancer early onset) • CHEK2 (Checkpoint kinase 2) • RAD51B (RAD51 Paralog B) • BRIP1 (BRCA1 Interacting Protein C-terminal Helicase 1) • RAD51C (RAD51 paralog C) • RAD51D (RAD51 paralog D) • CHEK1 (Checkpoint kinase 1) • BARD1 (BRCA1 Associated RING Domain 1) • RAD54L (DNA Repair And Recombination Protein RAD54) • FANCL (FA Complementation Group L) • PPP2R2A (Protein Phosphatase 2, Regulatory Subunit B, Alpha)
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BRCA1 mutation • ATM mutation • PALB2 mutation • CDK12 mutation • CHEK2 mutation • BRIP1 mutation • RAD51C mutation • RAD51D mutation • RAD51B mutation • BARD1 mutation • CHEK1 mutation • RAD54L mutation
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berzosertib (M6620) • Trodelvy (sacituzumab govitecan-hziy)
15d
DF1001-001: Study of DF1001 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
P1/2, N=270, Completed, Dragonfly Therapeutics | Recruiting --> Completed | Trial completion date: Dec 2026 --> Dec 2025 | Trial primary completion date: Oct 2026 --> Dec 2025
Trial completion • Trial completion date • Trial primary completion date • First-in-human
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 positive • HER-2 overexpression • HER-2 negative • HER-2 mutation • HER-2 positive + HER-2 overexpression
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HercepTest
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Opdivo (nivolumab) • albumin-bound paclitaxel • Trodelvy (sacituzumab govitecan-hziy) • DF1001
16d
Enrollment change
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EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
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Opdivo (nivolumab) • cisplatin • carboplatin • docetaxel • albumin-bound paclitaxel • pemetrexed • Yutuo (zimberelimab) • Trodelvy (sacituzumab govitecan-hziy) • domvanalimab (AB154) • etrumadenant (AB928)
17d
Study to Evaluate Sacituzumab Govitecan in Combination With Talazoparib in Patients With Metastatic Breast Cancer. (clinicaltrials.gov)
P1/2, N=75, Active, not recruiting, Massachusetts General Hospital | Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2025 --> Jun 2026
Enrollment closed • Trial primary completion date
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HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
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HER-2 positive • HER-2 negative • ER negative
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Talzenna (talazoparib) • Trodelvy (sacituzumab govitecan-hziy)